Verifie the sequelae of zika virus infection in fetuses and infants born of mothers with had the infection during the pregnancy , particularly the involvement by microcephaly . This study aims to include healthy pregnant in the first trimester of pregnancy and follow them throughout the pregnancy and babies born of these being pregnant that were affected or not by the virus zika
Conditions
Interventions
There is no intervention in the groups in study. This is a comparative observational study of babies born to pregnant women who had the infection zika virus during pregnancy and pregnant women who did
Other
V03.175.500
E05.318.308.980
E05.295.750
M01.526.485.500
E01.370.225.998.110
Sponsors
Fundação Oswaldo Cruz
National Institutes of Health
Eligibility
Age
15 Years to 45 Years
Inclusion criteria
Inclusion criteria: PREGNANCY Consent; Older than 15 years; Authorization and consent provided by local law; Pregnancy confirm by measuring beta hCG blood / urine or through fetal heartbeat on ultrasound exam; Proof that the participant is in first trimester of pregnancy (between 4 and 12 weeks) by gestational calculator or fetal ultrasound; NEWBORN All children born to women enrolled in the observational cohort are eligible for the study
Exclusion criteria
Exclusion criteria: PREGNANCY Women who can´t join the proposed protocol program; Pregnant women enrolled in other studies , including other research ZIKV; NEWBORN If the legal representant of the child doesn´t consent to the child to participate to the study; Babies born to mothers who aren´t partipate of the ZIP cohort study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected to estimate the incidence of congenital malformations and adverse outcomes (including microcephaly, fetuses death, neonatal death, CNS malformations, dropsy and ocular problems) in fetuses/newborn of women who are infected with ZIKV and those who were not infected | — |
Secondary
| Measure | Time frame |
|---|---|
| Malformation in neurodeveloping in the first year of life in babies borned ;;Expected to estimate the seroconversion rate of Zika virus in pregnant women monitored in endemic regions ;Expected to estimate the rate of incidence of long-term clinical sequelae in infected children | — |
Countries
Brazil, Colombia, Guatemala, Nicaragua, Puerto Rico, United States
Contacts
Public ContactMaria Moreira
Fundação Oswaldo Cruz
Outcome results
None listed